(62 days)
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.
The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory. The At Home Drug Cup, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / complexes.
The At Home Drug Cup (Model 9150X) is an immunoassay for the qualitative detection of amphetamine, MDA, methamphetamine, MDMA, THC, cocaine, and opiates in urine. The device's performance was evaluated through a clinical sample correlation study and a blind labeled spiked study.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "excellent overall accuracy" claims and correlation percentage. Specific, explicit acceptance criteria (e.g., "must achieve >95% accuracy") are not provided in the document.
| Drug/Metabolite | Cut-off Concentration (ng/ml) | Reported Device Performance (Correlation Study) | Reported Device Performance (Clinical Studies - Professional Users) | Reported Device Performance (Consumer Study - Lay Users) |
|---|---|---|---|---|
| Amphetamine | 1000 | >98% correlation to Behring EMIT II and GC/MS | >97% overall accuracy | 388/400 correct (97% overall accuracy) |
| MDA | 1000 | >98% correlation to Behring EMIT II and GC/MS | >97% overall accuracy | 388/400 correct (97% overall accuracy) |
| Methamphetamine | 500 | >98% correlation to Behring EMIT II and GC/MS | >97% overall accuracy | 388/400 correct (97% overall accuracy) |
| MDMA | 500 | >98% correlation to Behring EMIT II and GC/MS | >97% overall accuracy | 388/400 correct (97% overall accuracy) |
| THC (marijuana) | 50 | >98% correlation to Behring EMIT II and GC/MS | >97% overall accuracy | 388/400 correct (97% overall accuracy) |
| Cocaine | 300 | >98% correlation to Behring EMIT II and GC/MS | >97% overall accuracy | 388/400 correct (97% overall accuracy) |
| Opiates | 300 | >98% correlation to Behring EMIT II and GC/MS | >97% overall accuracy | 388/400 correct (97% overall accuracy) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the "Correlations studies, using clinical specimens," the specific sample size is not provided, only the resulting correlation percentage.
- For the "Clinical studies, performed at two independent laboratories" (professional user study), the specific sample size is not provided.
- For the "consumer study," the sample size was 400 cases (resulting in 388 correct interpretations).
- Data Provenance: The document does not explicitly state the country of origin for the clinical specimens or the location of the independent laboratories. The studies appear to be prospective as they are described as performance evaluation studies for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Correlation Study: The ground truth was established by two methods:
- Behring EMIT II: This is another commercially available drug screening test. While it's a device, its results are considered a form of established truth in this context.
- GC/MS methodology: Gas Chromatography-Mass Spectrometry (GC/MS) is a highly accurate analytical method often used as a gold standard for drug detection and quantification.
- Clinical Studies (Professional Users): The document doesn't explicitly state the number or qualifications of "professional users," but implies they are trained personnel in laboratory settings.
- Consumer Study (Lay Users): The ground truth against which lay users' interpretations were compared is not explicitly detailed but would presumably have been established by laboratory methods (like GC/MS or EMIT II) on the same samples.
4. Adjudication Method for the Test Set
The document does not describe a particular adjudication method (like 2+1, 3+1) for resolving discrepancies in the ground truth establishment. For the correlation study, the comparison was made against established laboratory methods (EMIT II and GC/MS), which inherently provide a single result. For the consumer study, the "correct" result was presumably pre-determined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No evidence of MRMC study: The document does not describe a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance. The device is a standalone immunoassay kit, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance
- Yes, standalone performance was done: The entire evaluation focuses on the standalone performance of the "At Home Drug Cup." Both the clinical sample correlation study and the consumer study assess the device's ability to detect target drugs independently. The clinical studies with professional users also represent standalone performance.
7. Type of Ground Truth Used
- Expert Consensus/Reference Method:
- For the correlation studies, the ground truth was established using reference laboratory methods, specifically the Behring EMIT II and Gas Chromatography-Mass Spectrometry (GC/MS). GC/MS is widely considered a gold standard in toxicology.
- For the clinical and consumer studies, the "correct" result against which the device's accuracy was measured would have been derived from these or similar established laboratory methods.
8. Sample Size for the Training Set
- The document does not mention a "training set" or "training data." As an immunoassay device, it is not an AI/ML algorithm that undergoes a training phase with a distinct dataset. Its performance is inherent to its biochemical design.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device.
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APR 1 4 2003
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: At Home Drug Cup (Model 9150X)
Description: Immunoassay for the qualitative detection of amphetamine, MDA methamphetamine, MDMA, THC, cocaine and opiates in urine
| Name Of Manufacturer: | Phamatech9530 Padgett Street, Suite 101San Diego, California 92126, USA |
|---|---|
| ----------------------- | --------------------------------------------------------------------------------- |
Intended Use: The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.
The At Home Drug Cup, like many commercially available drug screening test Technology: kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the QuickScreen At Home Drug Test (9150T) and the Applied Biotech SureStep Test (San Diego, CA 92121). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / complexes.
Performance: The product performance characteristics of the At Home Drug Cup were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech At Home Drug Cup to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the stated target drugs in urine. Correlations studies, using clinical specimens. produced a >98% correlation when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology. Clinical studies, performed at two independent laboratories, were also performed. In them the Phamatech At Home Drug Test™ exhibited excellent overall accuracy (>97%) in the hands of professional users. A comsumer study was also performed. The At Home Drug Cup exhibited excellent overall accuracy (388/400 correct or 97%) in the hands of lay users.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Home Drug Cup Model 9150X is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the lay user.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three wavy lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 4 2003
Mr. Carl Mongiovi Vice President Pharmatech, Inc. 9530 Padgett Street - Suite 101 San Diego, CA 92126
Re: K030447 Trade/Device Name: At Home Drug Cup (Model 9150X) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: MVO; LAF; DKZ; DIO; DJG; LDJ Dated: March 17, 2003 Received: March 24, 2003
Dear Mr. Mongiovi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: At Home Drug Cup (Model 9150X)
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
Jean Cooper
Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number:
OR
Prescription Use: Per 21 CFR 801.109 Over the Counter: v
N/A